Skip to content

PTK787/ZK 222584 in Treating Patients With Unresectable Malignant Mesothelioma

A Phase II Study of PTK787/ZK222584 (NSC#719335) in Patients With Unresectable Malignant Mesothelioma

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00053885
Enrollment
47
Registered
2003-02-06
Start date
2003-07-31
Completion date
2006-06-30
Last updated
2016-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Mesothelioma

Keywords

advanced malignant mesothelioma, epithelial mesothelioma, recurrent malignant mesothelioma, sarcomatous mesothelioma

Brief summary

RATIONALE: PTK787/ZK 222584 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase II trial to study the effectiveness of PTK787/ZK 222584 in treating patients with unresectable malignant mesothelioma.

Detailed description

OBJECTIVES: * Determine the efficacy of PTK787/ZK 222584, in terms of 3-month progression-free survival, in patients with malignant mesothelioma. * Determine the response rate in patients treated with this drug. * Determine the toxicity of this drug in these patients. * Determine the overall and failure-free survival of patients treated with this drug. * Correlate pretreatment circulating serum levels of vascular endothelial growth factor (VEGF), platelet-derived growth factor, and VEGF mRNA isoforms with response in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive oral PTK787/ZK 222584 daily. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, and then every 6 months for 1 year.

Interventions

Sponsors

Alliance for Clinical Trials in Oncology
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically confirmed malignant mesothelioma of 1 of the following types: * Epithelial * Sarcomatoid * Mixed * Not amenable to radiotherapy or curative surgery * Any site of origin including, but not limited to, the following: * Pleura * Peritoneum * Pericardium * Tunica vaginalis * At least one unidimensionally measurable lesion outside of prior irradiation port * At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * The following are not considered measurable: * Bone lesions * Leptomeningeal disease * Ascites * Pleural/pericardial effusion * Lymphangitis cutis/pulmonis * Abdominal masses that are not confirmed and followed by imaging techniques * Cystic lesions * No known brain metastases PATIENT CHARACTERISTICS: Age * Over 18 Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST no greater than 2.5 times ULN Renal * Creatinine no greater than 1.5 times ULN * Negative for proteinuria by dipstick OR * Urinary protein no greater than 500 mg and creatinine clearance at least 50 mL/min Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective double-barrier contraception * No currently active second malignancy except non-melanoma skin cancers (unless therapy is completed and risk of relapse is less than 30%) * No other concurrent uncontrolled illness * No ongoing active infections * No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * No prior signal transduction inhibitor therapy * No prior angiogenesis inhibitor therapy Chemotherapy * No prior cytotoxic chemotherapy for this malignancy * No concurrent chemotherapeutic agents * Prior intrapleural cytotoxic or sclerosing therapy (including bleomycin) allowed Endocrine therapy * No concurrent hormonal therapy except steroids for adrenal failure or hormones for non-disease-related conditions (e.g., insulin for diabetes) Radiotherapy * See Disease Characteristics * At least 4 weeks since prior radiotherapy * No concurrent palliative radiotherapy Surgery * See Disease Characteristics * At least 2 weeks since prior major surgery Other * At least 30 days since prior investigational agents * At least 7 days since prior grapefruit or grapefruit juice * At least 7 days since prior CYP3A4 inducers * No prior PTK787/ZK 222584 * No prior tyrosine kinase inhibitor therapy * No other concurrent investigational agents * No concurrent isoenzyme inducers or inhibitors of p450 * No concurrent warfarin or similar oral anticoagulants * Heparin allowed * No concurrent grapefruit or grapefruit juice * No concurrent combination antiretroviral therapy for HIV-positive patients

Design outcomes

Primary

MeasureTime frame
SurvivalUp to 3 years post-treatment
Failure free survivalUp to 3 years post-treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026